Stay Ahead of the FDA: Process Mapping, Gap Analysis and SOP Review

2020-bl-cqg-quality-mgmt-trends_715x320For Life Science Companies

What happens when the FDA arrives at your manufacturing facility? Your first reaction may be panic or perhaps regret for not having solved any wayward problems the inspection team will surely now find. But it does not have to be that way. In fact, by preparing in advance and using the right tools, a firm should be able to greet the FDA by saying, "Excellent. Everyone knows what to do. Let's get right to it." That is the exact attitude companies need to have to successfully pass any inspection.

During an inspection, a facility must be able to demonstrate that it is in a state of control. It may do so by having quality systems in place, knowing what the FDA expects and monitoring these systems. However, no matter how compliant a quality system is, if the manufacturer cannot successfully articulate it, the FDA will not get the message. As far as the agency is concerned, if something is not clear, then it is not happening at all.

That is where process mapping and gap analysis come in. Not only do they help manufacturers show the FDA that a company is in compliance with regulations, they also help demonstrate that SOPs are correct and that employees understand them.

Process Mapping

Processes are to be in a state of control. Assuring that a process is in a state of control begins with defining what that process entails. All facilities maintain voluminous SOPs for exactly this reason. But the FDA wants to see that SOPs are not just resting in drawers, but are translated into action. Process maps become the tools for doing that. Process maps are the visual representation of SOPs, regardless of what quality system they address. The process map is the snapshot of how any given process is maintained in a state of control.


The first step in any successful process mapping effort is putting together the right resources. This requires assigning at least one project manager, whether for one department or the entire site. Someone must fill the role of Facilitator. This could be the manager or it could be a separate staff member who works with the various areas to put the process mappings together.

In the case of a facility with multiple processes and systems, it can be too much for one person to manage the operation successfully; that makes administrative assistance necessary. It is also crucial to have good software. Word, Excel, Visio and SmartDraw are examples of packages that allow for mapping and flowcharts.

It is important that a firm not carry out any process mapping in a vacuum or silo. The facilitator must work with teams from around the facility. These teams are defined by system. If the process being mapped pertains to a single area of one department, intradepartmental personnel will suffice. However, if the process involves materials spread among several departments, a cross-functional team should be built. In addition, subject matter experts (scientists, quality managers, or production personnel) need to be identified to accompany any given process maps.

There are a number of outside organizations that offer process map training. Any training should include a facilitation format keeping the learning process within an interactive format. Brainstorming and nominal group techniques are crucial not only in learning process mapping but in successfully implementing it.

It is also possible for manufacturers to conduct their own training in-house. Training should demonstrate an effective way for employees to begin learning the meaning of the various flowchart symbols, understanding how the process is supposed to work, how the SOP and map relate to each other, and how to use the mappings to conduct gap analyses.

A good facilitator will explain how to link maps to current SOPs, rather than simply explain the inherent concepts. Attendees should be walked through each of the following steps: developing effective process mapping teams, creating detailed process maps, performing gap analysis and determining whether to revise or write SOPs to close compliance gaps. It is important that the attendees know they have to be active participants, not only during the training but once they are on a team as well. There can be no passive learners.

One area that many firms leave out of any training exercise is the front office. It may seem overly obvious, but isn't your receptionist the first person to greet any FDA official who walks in the door! If that employee seems nervous and unsure of what to do, that creates an impression. And that first impression is going to stay with the inspector throughout the rest of the visit. Everyone in the company, including support staff, should learn respond positively to a visit from the FDA or any other agency.


Process maps can take different forms, portray several levels of detail, and satisfy multiple purposes. The following examples represent actual situations from consultative efforts by the author.

Example 1: Following is a map of an investigation system. While the company's SOPs may be dozens of pages long, this map provides an overview of the process, often called the "50,000 foot view." This map visualizes what starts an investigation, its process and decision-trees and approval for quality and effectiveness. Note the number of decision trees in the process map that are nearly indiscernible in the form of an SOP. By creating this map, the manufacturer provides its employees with an easy-to-follow flowchart that takes them through the process, demonstrating visually how their investigation system works.

Example 2: By using process mapping, a company can help its employees visualize complex, detailed procedures or processes. This example demonstrates a more detailed process mapping of the Inputs, Outputs and Responsibilities associated with the Notification of Event (a.k.a. NOE) process. Note that this is "drill-down" element of the high level mapping of an investigation system (see Example 1). In addition to detailing this element of an investigation process, this "swimming lane" style of process mapping clarifies the actions contributing to the process (Inputs) and the expectations of input responsibility. Outcomes and associated responsibilities are also portrayed. Even more, this type of mapping can serve as an excellent training tool.

Example 3: Process maps may also be used to solve known problems. For instance, one firm kept losing batch records and couldn't complete investigations or batch record reviews (not good from a regulatory standpoint!). The company mapped out the path of its records revealing dozens of paths as the records moved back and forth among different areas and reviewers. With this first mapping, we can see that the process looks like spaghetti—a tangled web of activity.

Seeing the process laid out visually allowed the manufacturer to revisit the physical layout of its operations. As portrayed in the second mapping, quality approval and batch record release were moved into the same space, cutting down on the need for records to move between them. Two different production review units were consolidated. To stop the motion of the records, corrections are now made in the review units rather than shipping the records between the reviewers and the operators. After implementing these changes, the firm stopped losing batch records, maintained control of its batch record review system and improved their batch release process. In this way, process mapping can be used not just for an SOP, but for an entire system.

Gap Analysis and Preparing for Inspections

Even the most properly written SOP won't be followed correctly if it cannot be visualized. In some cases, employees might use a practice that is better than that in the SOP. Worse, they may be using a practice that is wrong. In order to find such compliance problem area, manufacturers should create process maps of all practices—what is actually happening in the facility—and compare them against SOPs and regulations.

This "gap analysis" will identify differences between activities and expectations in the SOPs. Once found, either the SOPs or the practices can be revised, resulting in a new process map. Another tactic that firms use is the creation of a "future state" -- a process map of the ideal way to function that can then become the new SOP and practice.

This same technique is then utilized to conduct a gap analysis of procedures and practices with FDA regulations, guidance documents and audit response commitments. A regulatory gap analysis is strategic to staying ahead of the FDA.

To start this process, management must be responsible for the development of a comprehensive action plan that brings together mapping, quality system element reviews, SOP reviews and gap analysis, and that then compares them to regulatory expectations. Management must also support a problem-solving and communicative organizational culture, as opposed to leaving any one department to work in a vacuum.


Regulatory inspection is a verification activity, one that serves to give the agency (and general public) assurance that manufacturers are in control. The key factor in all this is the ability to clearly communicate one's quality system. That is where process map come in. The maps represent a visual way of telling an inspector how a system works. Internally, they also serve to identify compliance hotspots (gaps!) well before the FDA finds them. Even if any identified problems are not closed out by the time an inspector arrives, a company can show it has identified them and has in place an action plan to correct them.

The important steps include taking the same view of the six quality systems that the FDA has, as well as properly managing them according to agency regulations and guidance. Firms should also map processes and identify any gaps. Gathering and analyzing metrics is also crucial.

FDA Commissioner Hamburg has publically stated that companies must have the right systems in place. They also must be able to demonstrate that they have those systems in place and to transparently show that they work. What better way to demonstrate this than with process mapping!

Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Training/Learning & Development.

In 1977, Kerry graduated from James Madison University in Harrisonburg, VA (B.S., Chemistry). He has received qualifications and certifications in the areas of facilitation and training, including instructional design and competency-based curricula. Kerry also received local and national awards for chapter management during his tenure as President of the Blue Ridge Section of the American Society for Quality Control, now the ASQ. Other past affiliations have included ASTD, PDA, GMP-TEA, ASPI, and AQP. Kerry is also an Advanced Toastmaster (

In 2006, Kerry founded Summit Consulting, Inc. (a Virginia-based corporation). Summit Consulting offers a combination of business and hands-on experience along with its consultation, training and mentoring services for the pharmaceutical manufacturing industry. The mission of Summit Consulting is to help clients fulfill their immediate needs and tasks, determine their peak potentials, and attain the next level in their success.

Summit is currently providing remediation efforts, public and private training seminars on regulatory compliance topics, and GMP mentoring for the pharmaceutical manufacturing arena, both domestically and in Europe. This combination is founded on more than 30 years experience and service in project management of regulatory compliance systems, quality assurance, quality management systems, auditing, design and presentation of regulatory training, employee development, and documentation. Kerry can be reached at (540) 246-3379 or

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